Spinal device company Expanding Orthopedics has started enrolling patients in a multi-centre, post-market clinical study of its pedicle screw system in Germany.
The XPED expanding pedicle screw system, which is commercially available in Europe, is designed to provide improved anchoring of the implant in the vertebral body.
The study, which will enrol up to 50 patients, is designed to assess the performance and usability of the pedicle screw system.
The study will follow patients for up to 24 months using pain and quality-of-life questionnaires as well as radiographic assessments.
St Bonifatius Hospital neuro traumatology department spine surgery head and study principal investigator Dr Klassen said the study is designed to gather clinical data using the XPED system across various patients.
"These patients typically require enhanced anchoring solutions to obtain sustainable long-term stability of the spine," Klassen said.
"Today we are using cement to augment pedicle screw fixation in weak bone, but believe that using the XPED will be safer and more efficient to treat our patients."
Klassen said that four patients had already been enrolled, and another 20 will be added to the study within six months.
Expanding Orthopedics CEO Ofer Bokobza said the company’s earliest patients using XPED system have now reached the two-year follow-up milestone, with encouraging results.
"Numerous surgeons in Europe have already selected the XPED as their preferred treatment option for treating patients with compromised bone but we expect the positive results of the study to give a strong base for the broad use of the XPED as the standard of care in Europe."